510(k) · Cleared
ClearedRespigraph-Respisomnograph-Respicentral
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nims/Respitrace Corp. · BZK Spirometer, Monitoring (W/Wo Alarm)
Cleared on Mar 6, 1987 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 109 later devices descend from it.
- Decided
- Mar 6, 1987
- Review
- 84 days
- Class
- Class II
- Product code
- BZK
- Recalls
- None
- Predicates
- 0
109 later devices descend from it, 1 citing it directly.
- This deviceK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- Descendant · cites it directly · 108 of its ownK983629 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999
- Descendant · 2 generations on · 83 of its ownK063270 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 61 of its ownK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 43 of its ownK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- Descendant · 5 generations on · 37 of its ownK123291 TruebeamVarian Medical Systems, Inc. · 2012
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 109 · See all- K983629RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999 · cites it directly108descendants
- K063270RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 2006 · 2 generations on83descendants
- K092871Trilogy MXVarian Medical Systems, Inc. · 2009 · 3 generations on61descendants
- K111106TruebeamVarian Medical Systems, Inc. · 2011 · 4 generations on43descendants
- K123291TruebeamVarian Medical Systems, Inc. · 2012 · 5 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K864886 | Respigraph-Respisomnograph-Respicentral | Nims/Respitrace Corp. | 1987 | — |
| +1 | K983629 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 1999 | — |
| +2 | K063270 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 2006 | 1 |
| +3 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| +4 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| +5 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 8 | 0 |
| 2018 | 7 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 10 | 0 |
| 2022 | 6 | 0 |
| 2023 | 10 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 9 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZK device
- #1 K260226 ElintMAX Respiratory Monitor (ElintMAX Monitor…score 19.5 · 26 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (109)
See all 1091 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983629 | RPM Respiratory Gating System | 1999 | 108 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K983629 (Varian Medical Systems, Inc., 1999) has gone furthest, with 108 descendants of its own.
How does its category compare?
All BZK devicesBZK Spirometer, Monitoring (W/Wo Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZK
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · BZK
71in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZK
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZK
2in 2020
MAUDE reports naming product code BZK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 71 | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 2 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K864886 · printed Nov 6, 2026
Cite this page
510(k) Report. “K864886: Respigraph-Respisomnograph-Respicentral.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K864886
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026